Med Tech-related technology assessments and clinical guidelines from NICE in the second half of April 2018

18

May 2018

Interventional Procedure Guidance is developed for most of the novel interventional procedures entering the English market. The program focuses solely on the clinical evidence. Recommendations may vary from ‘for research only’ to ‘for use with standard arrangements for clinical governance, consent, and audit.' Recommendations are not binding, although they are followed by providers and commissioners.

In the second half of April NICE published four new Interventional Procedure Guidance:

  • Interventional procedures guidance Robot-assisted kidney transplant, which covers evidence-based recommendations for the surgeon using a robot to help with a kidney transplant. Current evidence on the safety and efficacy of robot-assisted kidney transplant is limited in quantity and quality. For patients with obesity who would not otherwise be able to have a kidney transplant without an unacceptable risk of morbidity, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. In patients for whom open kidney transplant surgery is suitable, this procedure should only be used in the context of research.
  • Interventional procedures guidance Nerve transfer to partially restore upper limb function in tetraplegia, which covers evidence-based recommendations on nerve transfer to partially restore upper limb function in people with tetraplegia. The evidence on the efficacy of nerve transfer to partially restore upper limb function in tetraplegia is limited in quantity. There are no major safety concerns. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
  • Interventional procedures guidance Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia, which covers evidence-based recommendations on prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia in adults. Current evidence on the safety and efficacy of prostate artery embolisation for benign prostatic hyperplasia is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent, and audit.
  • Interventional procedures guidance Microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma, which covers evidence-based recommendations on on microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma in adults. Evidence on the safety and efficacy of microinvasive subconjunctival insertion of a trans-scleral gelatin stent for primary open-angle glaucoma is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

MedTech Innovation Briefing is the NICE's advice program for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

Two new Medtech Innovation Briefings, Noctura 400 Sleep Mask for diabetic retinopathy and diabetic macular oedema (used for treating diabetic retinopathy and diabetic macular oedema) and Curos disinfecting cap for needleless connectors (used on needleless connectors on vascular access devices), have been published the second half of April.

Diagnostics guidance evaluates new, innovative diagnostic technologies. It includes all types of measurements and tests that are used to assess a patient's condition. The guidance helps people in the NHS make efficient, cost-effective and consistent decisions about adopting new products. It supports innovation, transformation and improves healthcare delivery.

In the second half of April NICE published one new Diagnostics Guidance Adjunctive colposcopy technologies for assessing suspected cervical abnormalities: the DYSIS colposcope with DYSISmap and the ZedScan I. Further research is recommended on the effects of using the DYSIS colposcope with DYSISmap on clinical and patient outcomes in a human papilloma virus primary screening setting, and on patient experience. The ZedScan I shows promise in assessing suspected cervical abnormalities, but there is currently not enough evidence to recommend its routine adoption. Colposcopy services that implemented the ZedScan I before this guidance was published are encouraged to take part in studies that address these research recommendations.

See full details here.

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